President's Commission on Combating Drug ... - WhiteHouse.gov

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The Commission recommends that the Administration develop a model training program to be disseminated ...... potential s
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Table of Contents Chairman’s Letter ............................................................................................................................ 5 Summary of Recommendations.....................................................................................................14 The Drug Addiction and Opioid Crisis.......................................................................................... 21 Origins of the Current Crisis ......................................................................................................21 Magnitude and Demographics ...................................................................................................25 Newly Emerging Threats ...........................................................................................................28 Pathways to Opioid Use Disorder (Including Heroin) from Prescription Opioids ....................29 Health, Financial, and Social Consequences .............................................................................31 Drug Overdose Deaths ...............................................................................................................34 Substance Use Treatment Availability....................................................................................... 34 Systems Approach to Solutions .................................................................................................38 Federal Funding and Programs ......................................................................................................39 Streamlining Federal Funding for Opioids and Consideration of State Administrators ............39 Funding Effective Opioid-Related Programs .............................................................................40 Opioid Addiction Prevention .........................................................................................................41 Evidence-based Prevention Programs ........................................................................................ 43 SBIRT as a School Prevention Strategy .................................................................................44 Mass Media Public Education Campaigns ................................................................................46 Media Campaign Focusing on Opioids ..................................................................................47 Opioid Prescription Practices .....................................................................................................49 Improving upon the CDC Guideline for Prescribing Opioids for Chronic Pain and Provider/Prescriber Education................................................................................................ 49 Enhancing Prescription Drug Monitoring Programs (PDMP) ...............................................54 Prescription Take-Back Programs and Drug Disposal ........................................................... 57 Pain Level as an HHS Evaluation Criteria .................................................................................58 Reimbursement for Non-Opioid Pain Treatments .....................................................................59 Reducing and Addressing the Availability of Illicit Opioids .....................................................60 Improving Data Collection and Analytics ..............................................................................60 Disrupting the Illicit Fentanyl Supply ....................................................................................63 Interdiction and Detection Challenges ...................................................................................65 Protecting First Responders from Harmful Effects Resulting from Exposure to Fentanyl and other Synthetic Opioids ..........................................................................................................67

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Opioid Addiction Treatment, Overdose Reversal, and Recovery .................................................69 Drug Addiction Treatment Services .......................................................................................... 69 Increase Screenings and Referrals to Treatment through CMS Quality Measures ................69 Evidence-based Improvements to Treatment .........................................................................70 Insurance and Reimbursement Barriers to Accessing MAT ..................................................71 Enforcing the Mental Health Parity and Addiction Equity Act (MHPAEA) ......................... 73 MAT in the Criminal Justice System .....................................................................................74 Drug Courts and Diversion Programs ....................................................................................75 Addiction Services Workforce and Training Needs............................................................... 76 Response to Overdose ................................................................................................................79 Expanded Access and Administration of Naloxone ............................................................... 79 Overdose to Treatment and Recovery ....................................................................................81 Recovery Support Services ........................................................................................................82 Impact on Families and Children ........................................................................................... 82 Supporting Collegiate Recovery and Changing the Culture on College Campuses ..............83 Employment Opportunities for Americans in Recovery ........................................................ 85 Support Recovery Housing ....................................................................................................86 Research & Development ..............................................................................................................88 New Pain, Overdose, and MAT Medications ............................................................................88 Medical Technology Devices.....................................................................................................90 FDA Post-Market Research and Surveillance Programs ........................................................... 91 Conclusion .....................................................................................................................................92 Current Federal Programs and Funding Landscape ......................................................................95 Overview ....................................................................................................................................95 FY 2018 Funding Specific to America’s Opioid Crisis ............................................................. 95 The Comprehensive Addiction and Recovery Act (CARA) ..................................................98 21st Century Cures Act ...........................................................................................................98 FY 2018 Consolidated Federal Drug Control Budget ............................................................... 99 Prevention............................................................................................................................... 99 Treatment and Recovery ......................................................................................................101 Domestic Law Enforcement .................................................................................................103 Interdiction ........................................................................................................................... 104 International Efforts .............................................................................................................105

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Charter, President’s Commission on Combating Drug Addiction and the Opioid Crisis ...........109 Appendices ..................................................................................................................................112 Appendix 1. Acronyms ...........................................................................................................115 Appendix 2. History of Opiate Use and Abuse .......................................................................117 Appendix 3. Interim Report, President’s Commission on Combating Drug Addiction and the Opioid Crisis ............................................................................................................................ 111 Appendix 4. Fentanyl Safety Recommendations for First Responders ..................................127 References ............................................................................................................................................ 128

Summary of Recommendations Federal Funding and Programs 1. The Commission urges Congress and the Administration to block grant federal funding for opioid-related and SUD-related activities to the states, where the battle is happening every day. There are multiple federal agencies and multiple grants within those agencies that cause states a significant administrative burden from an application and reporting perspective. Creating uniform block grants would allow more resources to be spent on administering lifesaving programs. This was a request to the Commission by nearly every Governor, regardless of party, across the country. 2. The Commission believes that ONDCP must establish a coordinated system for tracking all federally-funded initiatives, through support from HHS and DOJ. If we are to invest in combating this epidemic, we must invest in only those programs that achieve quantifiable goals and metrics. We are operating blindly today; ONDCP must establish a system of tracking and accountability. 3. To achieve accountability in federal programs, the Commission recommends that ONDCP review is a component of every federal program and that necessary funding is provided for implementation. Cooperation by federal agencies and the states must be mandated.

Opioid Addiction Prevention 4. The Commission recommends that Department of Education (DOE) collaborate with states on student assessment programs such as Screening, Brief Intervention and Referral to Treatment (SBIRT). SBIRT is a program that uses a screening tool by trained staff to identify at-risk youth who may need treatment. This should be deployed for adolescents in middle school, high school and college levels. This is a significant prevention tool. 5. The Commission recommends the Administration fund and collaborate with private sector and non-profit partners to design and implement a wide-reaching, national multi-platform media campaign addressing the hazards of substance use, the danger of opioids, and stigma. A similar mass media/educational campaign was launched during the AIDs public health crisis. Prescribing Guidelines, Regulations, Education 6. The Commission recommends HHS, the Department of Labor (DOL), VA/DOD, FDA, and ONDCP work with stakeholders to develop model statutes, regulations, and policies that ensure informed patient consent prior to an opioid prescription for chronic pain. Patients need to understand the risks, benefits and alternatives to taking opioids. This is not the standard today. 7. The Commission recommends that HHS coordinate the development of a national curriculum and standard of care for opioid prescribers. An updated set of guidelines for prescription pain medications should be established by an expert committee composed of various specialty

practices to supplement the CDC guideline that are specifically targeted to primary care physicians. 8. The Commission recommends that federal agencies work to collect participation data. Data on prescribing patterns should be matched with participation in continuing medical education data to determine program effectiveness and such analytics shared with clinicians and stakeholders such as state licensing boards. 9. The Commission recommends that the Administration develop a model training program to be disseminated to all levels of medical education (including all prescribers) on screening for substance use and mental health status to identify at risk patients. 10. The Commission recommends the Administration work with Congress to amend the Controlled Substances Act to allow the DEA to require that all prescribers desiring to be relicensed to prescribe opioids show participation in an approved continuing medical education program on opioid prescribing. 11. The Commission recommends that HHS, DOJ/DEA, ONDCP, and pharmacy associations train pharmacists on best practices to evaluate legitimacy of opioid prescriptions, and not penalize pharmacists for denying inappropriate prescriptions. PDMP Enhancements 12. The Commission recommends the Administration's support of the Prescription Drug Monitoring (PDMP) Act to mandate states that receive grant funds to comply with PDMP requirements, including data sharing. This Act directs DOJ to fund the establishment and maintenance of a data-sharing hub. 13. The Commission recommends federal agencies mandate PDMP checks, and consider amending requirements under the Emergency Medical Treatment and Labor Act (EMTALA), which requires hospitals to screen and stabilize patients in an emergency department, regardless of insurance status or ability to pay. 14. The Commission recommends that PDMP data integration with electronic health records, overdose episodes, and SUD-related decision support tools for providers is necessary to increase effectiveness. 15. The Commission recommends ONDCP and DEA increase electronic prescribing to prevent diversion and forgery. The DEA should revise regulations regarding electronic prescribing for controlled substances. 16. The Commission recommends that the Federal Government work with states to remove legal barriers and ensure PDMPs incorporate available overdose/naloxone deployment data, including the Department of Transportation’s (DOT) Emergency Medical Technician (EMT) overdose database. It is necessary to have overdose data/naloxone deployment data in the PDMP to allow users of the PDMP to assist patients.

Supply Reduction and Enforcement Strategies 17. The Commission recommends community-based stakeholders utilize Take Back Day to inform the public about drug screening and treatment services. The Commission encourages more hospitals/clinics and retail pharmacies to become year-round authorized collectors and explore the use of drug deactivation bags. 18. The Commission recommends that CMS remove pain survey questions entirely on patient satisfaction surveys, so that providers are never incentivized for offering opioids to raise their survey score. ONDCP and HHS should establish a policy to prevent hospital administrators from using patient ratings from CMS surveys improperly. 19. The Commission recommends CMS review and modify rate-setting policies that discourage the use of non-opioid treatments for pain, such as certain bundled payments that make alternative treatment options cost prohibitive for hospitals and doctors, particularly those options for treating immediate post-surgical pain. 20. The Commission recommends a federal effort to strengthen data collection activities enabling real-time surveillance of the opioid crisis at the national, state, local, and tribal levels. 21. The Commission recommends the Federal Government work with the states to develop and implement standardized rigorous drug testing procedures, forensic methods, and use of appropriate toxicology instrumentation in the investigation of drug-related deaths. We do not have sufficiently accurate and systematic data from medical examiners around the country to determine overdose deaths, both in their cause and the actual number of deaths. 22. The Commission recommends reinstituting the Arrestee Drug Abuse Monitoring (ADAM) program and the Drug Abuse Warning Network (DAWN) to improve data collection and provide resources for other promising surveillance systems. 23. The Commission recommends the enhancement of federal sentencing penalties for the trafficking of fentanyl and fentanyl analogues. 24. The Commission recommends that federal law enforcement agencies expressly target Drug Trafficking Organizations and other individuals who produce and sell counterfeit pills, including through the internet. 25. The Commission recommends that the Administration work with Congress to amend the law to give the DEA the authority to regulate the use of pill presses/tableting machines with requirements for the maintenance of records, inspections for verifying location and stated use, and security provisions. 26. The Commission recommends U.S. Customs and Border Protection (CBP) and the U.S. Postal Inspection Service (USPIS) use additional technologies and drug detection canines to expand efforts to intercept fentanyl (and other synthetic opioids) in envelopes and packages at international mail processing distribution centers. 27. The Commission recommends Congress and the Federal Government use advanced electronic data on international shipments from high-risk areas to identify international suppliers and their U.S.-based distributors.

28. The Commission recommends support of the Synthetics Trafficking and Overdose Prevention (STOP) Act and recommends the Federal Government work with the international community to implement the STOP Act in accordance with international laws and treaties. 29. The Commission recommends a coordinated federal/DEA effort to prevent, monitor and detect the diversion of prescription opioids, including licit fentanyl, for illicit distribution or use. 30. The Commission recommends the White House develop a national outreach plan for the Fentanyl Safety Recommendations for First Responders. Federal departments and agencies should partner with Governors and state fusion centers to develop and standardize data collection, analytics, and information-sharing related to first responder opioid-intoxication incidents.

Opioid Addiction Treatment, Overdose Reversal, and Recovery 31. The Commission recommends HHS, CMS, Substance Abuse and Mental Health Services Administration, the VA, and other federal agencies incorporate quality measures that address addiction screenings and treatment referrals. There is a great need to ensure that health care providers are screening for SUDs and know how to appropriately counsel, or refer a patient. HHS should review the scientific evidence on the latest OUD and SUD treatment options and collaborate with the U.S. Preventive Services Task Force (USPSTF) on provider recommendations. 32. The Commission recommends the adoption of process, outcome, and prognostic measures of treatment services as presented by the National Outcome Measurement and the American Society of Addiction Medicine (ASAM). Addiction is a chronic relapsing disease of the brain which affects multiple aspects of a person's life. Providers, practitioners, and funders often face challenges in helping individuals achieve positive long-term outcomes without relapse. 33. The Commission recommends HHS/CMS, the Indian Health Service (IHS), Tricare, the DEA, and the VA remove reimbursement and policy barriers to SUD treatment, including those, such as patient limits, that limit access to any forms of FDA-approved medicationassisted treatment (MAT), counseling, inpatient/residential treatment, and other treatment modalities, particularly fail-first protocols and frequent prior authorizations. All primary care providers employed by the above-mentioned health systems should screen for alcohol and drug use and, directly or through referral, provide treatment within 24 to 48 hours. 34. The Commission recommends HHS review and modify rate-setting (including policies that indirectly impact reimbursement) to better cover the true costs of providing SUD treatment, including inpatient psychiatric facility rates and outpatient provider rates. 35. Because the Department of Labor (DOL) regulates health care coverage provided by many large employers, the Commission recommends that Congress provide DOL increased authority to levy monetary penalties on insurers and funders, and permit DOL to launch investigations of health insurers independently for parity violations.

36. The Commission recommends that federal and state regulators should use a standardized tool that requires health plans to document and disclose their compliance strategies for nonquantitative treatment limitations (NQTL) parity. NQTLs include stringent prior authorization and medical necessity requirements. HHS, in consultation with DOL and Treasury, should review clinical guidelines and standards to support NQTL parity requirements. Private sector insurers, including employers, should review rate-setting strategies and revise rates when necessary to increase their network of addiction treatment professionals. 37. The Commission recommends the National Institute on Corrections (NIC), the Bureau of Justice Assistance (BJA), the Substance Abuse and Mental Health Services Administration (SAMHSA), and other national, state, local, and tribal stakeholders use medication-assisted treatment (MAT) with pre-trial detainees and continuing treatment upon release. 38. The Commission recommends DOJ broadly establish federal drug courts within the federal district court system in all 93 federal judicial districts. States, local units of government, and Indian tribal governments should apply for drug court grants established by 34 U.S.C. § 10611. Individuals with an SUD who violate probation terms with substance use should be diverted into drug court, rather than prison. 39. The Commission recommends the Federal Government partner with appropriate hospital and recovery organizations to expand the use of recovery coaches, especially in hard-hit areas. Insurance companies, federal health systems, and state payers should expand programs for hospital and primary case-based SUD treatment and referral services. Recovery coach programs have been extraordinarily effective in states that have them to help direct patients in crisis to appropriate treatment. Addiction and recovery specialists can also work with patients through technology and telemedicine, to expand their reach to underserved areas. 40. The Commission recommends the Health Resources and Services Administration (HRSA) prioritize addiction treatment knowledge across all health disciplines. Adequate resources are needed to recruit and increase the number of addiction-trained psychiatrists and other physicians, nurses, psychologists, social workers, physician assistants, and community health workers and facilitate deployment in needed regions and facilities. 41. The Commission recommends that federal agencies revise regulations and reimbursement policies to allow for SUD treatment via telemedicine. 42. The Commission recommends further use of the National Health Service Corp to supply needed health care workers to states and localities with higher than average opioid use and abuse. 43. The Commission recommends the National Highway Traffic Safety Administration (NHTSA) review its National Emergency Medical Services (EMS) Scope of Practice Model with respect to naloxone, and disseminate best practices for states that may need statutory or regulatory changes to allow Emergency Medical Technicians (EMT) to administer naloxone, including higher doses to account for the rising number of fentanyl overdoses. 44. The Commission recommends HHS implement naloxone co-prescribing pilot programs to confirm initial research and identify best practices. ONDCP should, in coordination with HHS, disseminate a summary of existing research on co-prescribing to stakeholders.

45. The Commission recommends HHS develop new guidance for Emergency Medical Treatment and Labor Act (EMTALA) compliance with regard to treating and stabilizing SUD patients and provide resources to incentivize hospitals to hire appropriate staff for their emergency rooms.

46. The Commission recommends that HHS implement guidelines and reimbursement policies for Recovery Support Services, including peer-to-peer programs, jobs and life skills training, supportive housing, and recovery housing. 47. The Commission recommends that HHS, the Substance Abuse and Mental Health Services Administration (SAMHSA), and the Administration on Children, Youth and Families (ACYF) should disseminate best practices for states regarding interventions and strategies to keep families together, when it can be done safely (e.g., using a relative for kinship care). These practices should include utilizing comprehensive family centered approaches and should ensure families have access to drug screening, substance use treatment, and parental support. Further, federal agencies should research promising models for pregnant and postpartum women with SUDs and their newborns, including screenings, treatment interventions, supportive housing, non-pharmacologic interventions for children born with neonatal abstinence syndrome, medication-assisted treatment (MAT) and other recovery supports. 48. The Commission recommends ONDCP, the Substance Abuse and Mental Health Services Administration (SAMHSA), and the Department of Education (DOE) identify successful college recovery programs, including "sober housing" on college campuses, and provide support and technical assistance to increase the number and capacity of high-quality programs to help students in recovery. 49. The Commission recommends that ONDCP, federal partners, including DOL, large employers, employee assistance programs, and recovery support organizations develop best practices on SUDs and the workplace. Employers need information for addressing employee alcohol and drug use, ensure that employees are able to seek help for SUDs through employee assistance programs or other means, supporting health and wellness, including SUD recovery, for employees, and hiring those in recovery. 50. The Commission recommends that ONDCP work with the DOJ, DOL, the National Alliance for Model State Drug Laws, the National Conference of State Legislatures, and other stakeholders to develop model state legislation/regulation for states to decouple felony convictions and eligibility for business/occupational licenses, where appropriate. 51. The Commission recommends that ONDCP, federal agencies, the National Alliance for Recovery Residents (NARR), the National Association of State Alcohol and Drug Abuse Directors (NASADAD), and housing stakeholders should work collaboratively to develop quality standards and best practices for recovery residences, including model state and local policies. These partners should identify barriers (such as zoning restrictions and discrimination against MAT patients) and develop strategies to address these issues.

Research and Development 52. The Commission recommends federal agencies, including HHS (National Institutes of Health, CDC, CMS, FDA, and the Substance Abuse and Mental Health Services Administration), DOJ, the Department of Defense (DOD), the VA, and ONDCP, should engage in a comprehensive review of existing research programs and establish goals for pain management and addiction research (both prevention and treatment). 53. The Commission recommends Congress and the Federal Government provide additional resources to the National Institute on Drug Abuse (NIDA), the National Institute of Mental Health (NIMH), and National Institute on Alcohol Abuse and Alcoholism (NIAAA) to fund the research areas cited above. NIDA should continue research in concert with the pharmaceutical industry to develop and test innovative medications for SUDs and OUDs, including long-acting injectables, more potent opioid antagonists to reverse overdose, drugs used for detoxification, and opioid vaccines. 54. The Commission recommends further research of Technology-Assisted Monitoring and Treatment for high-risk patients and SUD patients. CMS, FDA, and the United States Preventative Services Task Force (USPSTF) should implement a fast-track review process for any new evidence-based technology supporting SUD prevention and treatments. 55. The Commission recommends that commercial insurers and CMS fast-track creation of Healthcare Common Procedure Coding System (HCPCS) codes for FDA-approved technology-based treatments, digital interventions, and biomarker-based interventions. NIH should develop a means to evaluate behavior modification apps for effectiveness. 56. The Commission recommends that the FDA establish guidelines for post-market surveillance related to diversion, addiction, and other adverse consequences of controlled substances.

The Drug Addiction and Opioid Crisis The primary goal of the President’s Commission on Combating Drug Addiction and the Opioid Crisis is to develop an effective set of recommendations for the President to combat the opioid crisis and drug addiction in our nation. Many of the recommendations that follow will require appropriations from Congress into the Public Health Emergency Fund, for block grants to states and to DOJ for enforcement and judicial improvements. Notwithstanding this core mission, it is vital to address the influences that transformed the United States into the world leader of opioid prescribing, opioid addiction, and opioid overdose deaths. It is not the Commission's charge to quantify the amount of these resources, so we do not do so in this report. The Commission urges Congress to respond to the President's declaration of a public health emergency and fulfill their constitutionally delegated duty and appropriate sufficient funds to implement the Commission's recommendations. 175 Americans are dying every day. Congress must act.

Origins of the Current Crisis The Current Crisis. In the mid- to late-19th century, the first national opioid crisis occurred; a detailed history is provided in Appendix 2. During this time, opioid use rose dramatically, fueled by physicians’ unrestrained opioid prescriptions (morphine, laudanum, paregoric, codeine, and heroin) for pain or other ailments, and by liberal use of opioid-based treatments for injuries and diseases impacting Civil War combatants and veterans (see Appendix 2). In parallel with the current crisis, this nation-wide crisis extended across socio-economic statuses, and reached urban and rural areas. This first epidemic was eventually contained and reversed by physicians, pharmacists, medical education, and voluntary restraint, combined with federal regulations and law enforcement. After the first crisis subsided, medical education emphasized the hazards of improper opioid prescribing, and by doing so, created a cultural mindset against the dangers of opioids. However, over 30 years ago, a sequence of events eroded fears of opioids, and the medical community once again relapsed into liberal use of medicinal opioids. Triggered by excessive prescribing of opioids since 1999, the current crisis is being fueled by several factors that did not exist in the 19th century: the advent of large scale production and distribution of pure, potent, orally effective and addictive opioids; the widespread availability of inexpensive and purer illicit heroin; the influx of highly potent fentanyl/fentanyl analogs; the transition of prescription opioid misusers into use of heroin and fentanyl; and the production of illicit opioid pills containing deadly fentanyl(s) made by authentic pill presses. Prescription opioids now affect a wide age range, families both well-off and financially disadvantaged, urban and rural, and all ethnic and racial groups. Historical precedent demonstrated that this crisis can be fought with effective medical education, voluntary or involuntary changes in prescribing practices, and a strong regulatory and enforcement environment. The recommendations of the Commission are grounded in this reality, and benefit from modern systematic epidemiological and large data analytics, evidence-based treatments, and medications to assist in recovery or rescue of an overdose crisis. Contributors to the Current Crisis. A widely held and supportable view is that the modern opioid crisis originated within the healthcare system and have been influenced by several factors:



Unsubstantiated claims: One early catalyst can be traced to a single letter to the Editor of the New England Journal of Medicine published in 1980, that was then cited by over 600 subsequent articles.1,2 With the headline “Addiction Rare in Patients Treated with Narcotics,” the flawed conclusion of the five-sentence letter was based on scrutiny of records of hospitalized patients administered an opioid. It offered no information on opioid dose, number of doses, the duration of opioid treatment, whether opioids were consumed after hospital discharge, or long-term follow-up, nor a description of criteria used to designate opioid addiction. Six years later, another problematic study concluded that “opioid maintenance therapy can be a safe, salutary and more humane alternative to the options of surgery or no treatment in those patients with intractable 3 non-malignant pain and no history of drug abuse.” High quality evidence demonstrating that opioids can be used safely for chronic non-terminal pain did not exist at that time. These reports eroded the historical evidence (see Appendix 2) of iatrogenic addiction and aversion to opioids, with the poor- quality evidence that was unfortunately accepted by federal agencies and other oversight organizations.



Pain patient advocacy: Advocacy for pain management and/or the use of opioids4,5,6 by pain patients was promoted, not only by patients, but also by some physicians. One notable physician stated: “make pain ‘visible’… ensure patients a place in the communications loop… assess patient satisfaction; and work with narcotics control authorities to encourage therapeutic opiate use… therapeutic use of opiate analgesics rarely results in addiction.”7



The opioid pharmaceutical manufacturing and supply chain industry: One pharmaceutical company sponsored over 20,000 educational events for physicians and others on managing pain with opioids, claiming their potential for addiction was low.8 Yet, warning signs of the addictive potential of oxycodone and similar opioids long predated this period: in 1963, Bloomquist wrote that dihydrohydroxycodeinone (oxycodone, Percodan®), “although a useful analgesic retains addiction potential comparable to that of morphine. This fact should be considered when it is prescribed. Because of increasing numbers of addicts to this drug in the State of California, the California Medical Association Committee on Dangerous Drugs and the House of Delegates has recommended that oxycodone-containing drugs be returned to the triplicate prescription list as they were originally in 1949.” This recommendation failed to pass the legislature.9 Similar warnings followed. Aggressive promotion of an oxycodone brand from 1997-2002 led to a 10-fold rise in prescriptions to treat moderate to severe noncancer pain, and increases in prescribing of other opioids. Subsequently, the highest strengths permissible was increased for opioid-tolerant patients, likely contributing to its misuse. Extended-release (ER) formulations and delayed absorption were marketed as reducing abuse liability, but crushing the pills allowed users to snort or inject the drugs.10,11 There are now at least five marketed opioids that carry abusedeterrent labeling. It has been hypothesized that the marked rise in heroin and other illicit synthetic opioids is, in part, associated with unintended consequences of reformulation of OxyContin, and a reduced supply and greater expense of prescription opioids.12,13 To this day, the opioid pharmaceutical industry influences the nation’s response to the crisis.14 For example, during the comment phase of the guideline developed by the Centers for Disease Control and Prevention (CDC) for pain management, opposition to the guideline was more common among organizations with funding from opioid manufacturers than those without funding from the life sciences industry.15



Rogue pharmacies and unethical physician prescribing: The key contributors of the large number of diverted opioids were unrestrained distributors, rogue pharmacies, unethical

physicians, and patients whose opioid medications were diverted, or other patients who sold and profited from legitimately prescribed opioids.16 

Pain as the ‘fifth vital sign’: The phrase, “pain as the ‘fifth vital sign,’” was initially promoted by the American Pain Society in 1995, to elevate awareness of pain treatment among healthcare professionals; “Vital Signs are taken seriously. If pain were assessed with the same zeal as other vital signs are, it would have a much better chance of being treated properly. We need to train doctors and nurses to treat pain as a vital sign. Quality care means that pain is measured and treated.”17 The Veteran’s Administration (VA)18 and then the Joint Commission on Accreditation of Healthcare Organizations (the Joint Commission) designated pain as a ‘fifth vital sign.’19,20 The Joint Commission accredits and certifies health care organizations. Certification has implications for objective assessment of clinical excellence, and for contracting and reimbursement. The Joint Commission’s standards for pain assessment in 2000 “were a bold attempt to address widespread underassessment and undertreatment of pain,”21 even though the health care community was not advocating for a regulatory approach to pain management.22 The standards raised concerns that requiring all patients to be screened for the presence of pain and raising pain treatment to patients’ rights issue could lead to overreliance on opioids. The Joint Commission received sponsorship for developing educational materials from an opioid pharmaceutical company, one of over 20,000 pain-related educational programs through direct sponsorship or financial grants. It was “unaware that the science behind their claims and the advice of experts in the field were erroneous.”23 This designation set in motion a growing compulsion to detect and treat pain, especially to prescribe opioids beyond traditional boundaries of treating acute, postoperative, procedural pain and end-of-life care. The surge in opioid supply escalated into opioid-related misuse, diversion, use disorder, and overdose deaths. Administrators, regulatory bodies, and insurers collectively pressured physicians to address patient satisfaction with aggressive pain management.24 However, the concept that iatrogenic addiction was rare and that long-acting opioids were less addictive had been widely repeated, and studies refuting these claims were not published until years later. The Joint Commission has since eliminated the requirement that pain be assessed in all patients, except for patients receiving behavioral health care and established much stricter processes to review any corporate sponsorship of educational programs. In 2016, the Joint Commission began to revise its pain standards,25 which will go into effect in January 2018.



Inadequate oversight by the Food and Drug Administration (FDA): The FDA is the sole federal authority responsible for protecting public health by assuring the safety, efficacy, and security of human drugs, biological products, and medical devices. It approves medications to diagnose, treat, and mitigate illnesses, after assessing their safety and efficacy. It safeguards the nation’s medications by setting standards for proper prescribing of approved drugs and post-approval surveillance. The FDA provided inadequate regulatory oversight. Even when overdose deaths mounted and when evidence for safe use in chronic care was substantially lacking, prior to 2001, the FDA accepted claims that newly formulated opioids were not addictive, did not impose clinical trials of sufficient duration to detect addiction, or rigorous post-approval surveillance of adverse events, such as addiction.

The FDA also failed to assess the risks associated with deliberate diversion and misuse of opioids, risks that conceivably outweighed the intended benefits for patients if used as directed. They accepted the pharmaceutical industry’s claim that iatrogenic addiction was “very rare” and that the delayed absorption of OxyContin reduced the abuse liability of the drug.26 By 2001, the FDA removed these unsubstantiated claims from OxyContin’s labeling. In March 2016, the FDA requested from the National Academies of Sciences, Engineering, and Medicine (NASEM) and received on July 13, 2017, a summary of the current status of science regarding prescription opioid abuse and misuse, and the role of opioids in pain management.27 The current FDA Commissioner has stated a strong commitment to using the regulatory authority of the FDA to mitigate the adverse consequences of opioid use.28 

Reimbursement for prescription opioids by health care insurers: Sales of prescription opioids in the U.S. nearly quadrupled from 1999 to 2014,29 largely paid for by insurance carriers. It is estimated that 1 out of 5 patients with non-cancer pain or pain-related diagnoses are prescribed opioids in office-based settings.30 From 2007 to 2012, the rate of opioid prescribing steadily increased amongst specialists more likely to manage acute and chronic pain (pain medicine [49%], surgery [37%], physical medicine/rehabilitation [36%]). Insurance carriers, including Medicare Part D plans, did not serve as a stop-gap to the huge influx of opioid prescriptions.



Medical education: Medical education has been deficient in pain management, opioid prescribing, screening for, and treating addictions.31 During the 1990’s, the pain movement should have alerted medical education institutions and creators of continuing medical education courses to address this issue. In some medical schools and some specialties, it remains inadequate to this day.32 One strategy promoted 10 years ago to stratify patients’ risk for opioid misuse and overdose was the screening of patients for substance use disorders (SUDs), especially pain patients.33 Implementation of Screening, Brief Interventions, and Referral to Treatment (SBIRT) in healthcare systems was incentivized with billing codes. 34 SBIRT was mainstreamed into health care reform, but has yet to be incorporated nationally into medical curricula, or applied as routine care. Nor do core curricula necessarily address addictions, treatment options, or stress the need to screen for substance use and mental health.



Lack of patient education: Patients and their families are not often fully informed regarding whether their prescriptions are opioids, the risks of opioid addiction or overdose, control and diversion, dose escalation, or use with alcohol or benzodiazepines.



Public demand evolves into reimbursement and physician quality ratings pegged to patient satisfaction scores: Today, the use of opioids for chronic non-cancer pain remains controversial for the same reasons their use declined and was avoided at the turn of the 20th century: the potential for misuse and addiction, insufficient high-quality evidence of efficacy with long-term use, poor functional outcomes, overdose and death. Yet, a strong public demand for opioids continues to pressure clinicians to prescribe opioids persists. As an example, a recent survey of Emergency Department (ED) physicians indicated that 71% reported a perceived pressure to prescribe opioid analgesics to avoid administrative and regulatory criticism. Uniformly, they voiced concern about excessive emphasis on patient satisfaction scores by reimbursement entities as a means of evaluating their patient management. The physician requirement to address pain as the "fifth vital sign" persists,35

and reimbursement metrics based on patient satisfaction may have inadvertently created an environment conducive to exploitation by prescription opioid abusers.36 There are legitimate circumstances for which opioids are an appropriate therapy. But many current institutional and societal issues continue to pressure physicians to prescribe opioids when they are not clinically appropriate. Prior to this year, poor patient satisfaction with pain care could lead to reduced hospital reimbursement by Medicare through Value-Based Purchasing (VBP). There are often higher costs or no specific reimbursements for alternative pain management strategies, alternative pain intervention strategies, or spending time to educate patients about the risks of opioids. Further, failing to provide adequate pain relief can be grounds for malpractice claims or medical board action. 

Lack of foresight of unintended consequences: As prescription drugs came under tighter scrutiny and access became more limited (via abuse-deterrent formulations and more cautious prescribing), market forces responded by providing less expensive and more accessible illicit opioids. Increases in overdose death numbers due to prescription opioids have transitioned to overdoses largely due to heroin and, increasingly, fentanyl. 37 Locally, this trend may have been driven, in part, by tightening controls on prescription opioids. Physicians curtailed opioid prescriptions without guidelines on tapering and without determination of whether patients had developed an opioid use disorder (OUD), and if so, how to respond.38 The availability of cheaper heroin also drove prescription opioid misusers to illicit opioids. Black market heroin is currently much less expensive than diverted prescription opioids, and fentanyl is even much less expensive per dose than heroin. Predictable from the economics of the two drug categories, the prescription drug overdose problem has decreased, but not the overall number of opioid-related deaths.



Treatment services insufficient to meet demand and to provide medication-assisted treatment (MAT): As OUDs increased dramatically over the past 15 years, quality treatment services and the associated workforce did not expand in response to the growing crisis.



Lack of national prevention strategies: Prevention strategies focusing on specific illicit drugs for vulnerable populations - adolescents, college age youth, pregnant women, unemployed men, and other - and for influencers, (parents, families) don’t exist or have not been tested adequately.

Magnitude and Demographics National statistics on prescription opioid misuse and use disorder, 2016.39 Weighted National Survey on Drug Use and Health (NSDUH) estimates suggested that, in 2016, 91.8 million (34.1%) or more than one-third of U.S. civilian, noninstitutionalized adults used prescription opioids; 11.5 million (4.3%) misused them. In 2015, 1.6 million (0.7%) had an OUD. Among adults with prescription opioid use, 12.2% reported misuse and 15.1% of misusers reported a prescription OUD.40 The most commonly reported motivation for misuse was to relieve physical

pain (63.6%). Misuse and use disorders were most commonly reported in adults who were uninsured, were unemployed, had low income, or had behavioral health problems. Among adults with misuse, 62.2% reported using opioids without a prescription, and 40.6% obtained prescription opioids for free from friends or relatives for their most recent episode of misuse. The results suggest a need to improve access to evidence-based pain management and to decrease excessive prescribing that may leave unused opioids available for potential misuse.41 The NSDUH estimates that 3.4 million people aged 12 or older in 2016 were current misusers of pain relievers (1.2% of the population aged 12 or older).42 In 2016, an estimated 239,000 adolescents aged 12 to 17 were current misusers of pain relievers (1.0% of adolescents) and 631,000 young adults aged 18 to 25 misused pain relievers in the past month (1.8% of young adults). Among adults aged 26 or older, 2.5 million are estimated to be current misusers of pain reliever (1.2%). Upwards of 1.8 million Americans harbor an OUD involving prescription opioids or 0.7% of people aged 12 or older. Among adolescents aged 12 to 17, 152,000 (0.6%) had a pain reliever use disorder in the past year, and 291,000 young adults aged 18 to 25 (0.8%) and 1.3 million adults aged 26 or older in 2016 (0.6%) had a pain reliever use disorder in the past year. These small percentages do not convey the massive personal and public health burden created by misuse of opioids. National statistics on heroin use and use disorder, 2016.43 The addictive and illegal opioid heroin has no accepted medical use in the United States. Past 30 day users of heroin (475,000) among people aged 12 or older or 0.2% of the population is probably an underestimate because NSDUH surveys households and does not capture heroin users in homeless shelters or transient populations with no fixed address, and the incarcerated. Despite its dangers heroin use continues to escalate and reflects changes in heroin use by adults aged 26 or older and, to a lesser extent, among young adults aged 18 to 25. Less than 0.1% of adolescents aged 12 to 17 were current or past year heroin users (3,000 and 13,000, respectively) and these numbers remained relatively stable. Among young adults aged 18 to 25, 0.3% were current heroin users (88,000) and this number rose since 2002. For past year and at minimum, 630,000 individuals have a heroin use disorder (HUD).17 Among adults 26 and older 0.2% were current heroin users (383,000), a rise since 2015. About 626,000 people aged 12 or older reported an HUD (0.2%), an increase since 2002 to 2011. Less than 0.1% of adolescents aged 12 to 17 (1,000) had an HUD in the past year, but this rate was many times higher among 18-25-year-olds (152,000; 0.4%). Approximately 473,000 adults aged 26 or older had an HUD (0.2%) Substance use disorder treatment needs, 2016.44 For NSDUH, people are defined as needing substance use treatment if they had an SUD in the past year or if they received substance use treatment at a specialty facility in the past year. In 2016, 10.6% of people aged 12 or older (2.3 million people) who needed substance use treatment received treatment at a specialty facility in the past year. Among people in specific age groups needing substance use treatment, 8.2% of adolescents aged 12 to 17, 7.2% of young adults aged 18 to 25, and 12.1% of adults aged 26 or older received substance use treatment at a specialty facility in the past year. These percentages represent 89,000 adolescents, 383,000 young adults, and 1.8 million adults aged 26 or older who needed substance use treatment and received treatment at a specialty facility in the past year. Prior to 2016, NSDUH reported on the reasons people in need in treatment did not receive it. Approximately 90% self-reported they did not feel the need for treatment and did not seek it.

Special Populations. The Commission recognizes that, although many of the recommendations included in this report are generic for the population as a whole, subpopulations exist within our nation that conceivably require increased outreach, access to services, and more tailored or intensive services. These special populations can be viewed from the perspective of race or ethnicity, residential location and population density, gender, age45, mental46 and physical health status (e.g. HIV-AIDS), income, employment, socio-economic status, education, veterans,47,48 involvement in the criminal justice system (juveniles, parolees, incarcerated), family status (fetus49, children of substance-using parents or other family members, pregnant women, living alone), healthcare insurance sources, behavioral health indicators50 (other SUDs or history), type of opioid use (heroin/fentanyl, prescription opioid nonmedical or medical use, or combined use), and others. According to the 2016 NSDUH, more males (4.8%) than females (3.8%) misused prescription opioid medications.51 Young adults aged 18 to 25 years old had the largest proportion of misusers. In comparison to the national average for past year misuse of pain relievers by those 12 years and older, misuse was most common among Americans with two or more races (6.5%), American Indian or Alaska Natives (3.9%), Native Hawaiian or other Pacific Islanders (4.2%), and Hispanics (4.2%). The rate of non-medical use of prescription opioid medications was lowest among Asians (1.8%). Scrutiny of the NSDUH and other data sources can reveal which populations are at highest risk. A recent study using 2010-2013 NSDUH data52 revealed the prevalence of OUDs was highest among whites (72.29%), with lower prevalence among blacks (9.23%), Hispanics 13.82%, and others 4.66%. Other factors overrepresented among those reporting OUDs were adults aged 18– 34 (55.95%), males (57.39%), low income (